Recall Z-0639-2021— GA HEALTH COMPANY LIMITED
Class II · Terminated
Class II FDA medical device recall by GA HEALTH COMPANY LIMITED, initiated 2020-11-03, terminated 2021-09-03. It names 2 FDA 510(k) clearances: K182998, K181509. Product: STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229. Reason: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure.
- Recalling firm
- GA HEALTH COMPANY LIMITED
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-03
- Terminated
- 2021-09-03
- Firm location
- Shatin N.T., N/A, Hong Kong SAR
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229
Reason for recall
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Data sourced from openFDA. This site is unofficial and independent of the FDA.